Recall Z-2575-2021 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Medline Industries Inc
NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (3) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015012, UPN H965700150121, Four-way Stopcock with Rotating Collar, Rx o
| Date | Aug 6, 2021 |
| Status | Terminated |
| Reason | Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions. |
| Root cause | Process design |
| Action | The recalling firm issued letters dated and mailed on 8/6/2021 notifying consignees of the issue and requesting they immediately check their stock for the affected product and destroy it. |
| Quantity | 816,420 manifolds and stopcocks |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Australia, Japan, Latvia, Lebanon, Malaysia, Netherlands, Pakistan, People's Republic of China, Panama, Singapore, South Africa, South Korea, Thailand, and United Kingdom. |
| FDA record | Open on fda.gov |